Regulatory consulting services at competitive rates in the medical device and combination product industries

Theodore Nicholson

 
 

Theodore R. Nicholson III, PhD

principal consultant

Theodore has a PhD in biomedical engineering with over 14 years of experience in biological, chemical, and medical device product development. He spent the last 10 years navigating software design and development, regulatory, quality, risk, project management, clinical trials, and business aspects of medical device development projects in several regulatory environments. He has built teams across domains, led large cross-functional product development efforts, managed multi-site national clinical trials, and operated as an executive within the medical device space. Theo has worked in software as a medical device for 10 years in behavioral health, patient monitoring, remote patient monitoring, and critical care applications. His most recent experiences have been in the machine learning domain, applying the power of those analytical tools to complex diagnostic questions. During these efforts, he established cloud-based systems and performed cybersecurity risk assessment to inform design, development, and testing of medical devices. He has end-to-end software as a medical device experience.

His consulting firm, TRN3 Consulting LLC, also supports sustainable innovation in Healthcare, Energy, Agriculture, Water, and Housing Development. The main work centers underserved and underrepresented communities in the marketplace to close gaps and eliminate disparities that harm individuals in those communities. Theo enjoys helping projects that help people. Theo is a member of the external advisory committee at the Ohio State University Biomedical Engineering department and supports faculty programming as well as student mentoring.

For more information, please visit the TRN3 Consulting website or his LinkedIn Profile.